Topics
- Review of FDA software validation requirements
- Outline of FDA regulations as applied to software
- The 6 Most Common Problems in FDA Software Validation & Verification
- Why validation makes good business sense
- Advice on successful validation project staffing
- Strategies on how to avoid the most common problems
Who should Attend
Attendees from FDA regulated Medical Device, Pharmaceutical, Diagnostics, Biotech and Biological manufacturers, including:
- QA / QC managers, executives and personnel
- System owners - responsible for keeping individual systems in validation
- Validation specialists
- IT / IS managers and personnel
- Consultants
- Software quality reviewers
